Commercial Drug Substance Manufacture

WuXi Biologics maintains 460,000 sq. ft. of commercial drug substance and drug product cGMP manufacturing facilities in addition to our extensive existing CMC development and manufacturing capabilities. The commercial manufacturing campus is just down the street from our existing manufacturing site in Wuxi city.

Engineering (55,000 sq. ft.)

MST/QA (44,000 sq. ft.)

Commercial Manufacturing & QC (220,000 sq.ft.)

14 x 2,000L Fed-batch

2 x 1,000L Perfusion

Fill/Lyophilization/Finish (77,000 sq. ft.)

Warehouse (110,000 sq. ft.)

The new facility accommodates 2 x 1000L disposable bioreactors for perfusion processes and is the largest perfusion biologics manufacturing facility to date in Asia implementing disposable bioreactors (see press release). To learn more about our perfusion manufacturing capabilities including case studies see this webinar.

Beginning in Q3 2017 this campus will begin operating 14 x 2000L disposable bioreactors for fed-batch production of monoclonal antibodies, bi-specific antibodies, Fc-fusion proteins and other recombinant proteins produced from mammalian cell culture. The fed-batch production facility is currently the world’s largest commercial manufacturing facility utilizing single-use/disposable bioreactors (see press release).

Facility of the future

Taking advantage of the advancements in disposable manufacturing technologies and in response to market demands for commercial manufacturing operations that reduce risk, costs and offer greater flexibility and scalability for product supply, WuXi Biologics designed and built a state-of-the-art manufacturing facility for commercial supply of biological therapeutics. See below the advantages of our manufacturing approach.

Flexibility

Designed for multi-product production

Utilizes fed-batch or perfusion cell culture processes

Accommodates cell culture production platforms with a wide range of product titers (1-10g/L)

Able to manufacture mAbs, bi-specific abs, Fc-fusion proteins, ADCs and other recombinant proteins

Adapts to products with varying market demand from Orphan to Blockbuster biotherapeutics

Scalability

Production scheme adapts to product life cycle or market demand changes with minimal risk to product quality or process performance

Compliance

GMP Compliance to US FDA, EMA and CFDA standards and guidelines

Traditional room classification and campaign operation

Processes/Systems are highly automated and include data historian and Manufacturing Execution System (MES)

Scale Out vs. Scale Up Commercial Manufacturing

The use of 14 x 2,000 L bioreactors for commercial production is a paradigm changing “scale-out“ philosophy for commercial manufacturing. To understand the philosophy and benefits of the scale-out approach and for comparisons to the traditional “scale-up” manufacturing model scroll down the page.

What is Scale-out vs. Scale-up?

Scale-up manufacturing means using a larger bioreactor to produce the material needed for late stage clinical trials or market demand compared to the size of bioreactor used for early stage clinical production.

Scale-out manufacturing utilizes multiple bioreactors to produce late stage clinical material and market demand at the same size of bioreactor as used in early stage clinical trials.

Comparison of the advantages

Scale-up model

The current industry standard or status quo. It is well-known and expertise exists.

Many facilities and CMOs worldwide currently maintain scale-up capabilities.

This model is perceived as a cost effective means of production.

Scale-out model

Maintaining the same bioreactor size of cell culture manufacture between phases of development or market demand cycles means little risk to process and product quality as you scale-out.

Can develop design space and achieve high levels of process understanding very early in development making eventual validation effort faster and more efficient.

An adverse event in a single bioreactor does not mean the production lot is lost.

Utilize inherent advantages to single-use/disposable systems (risk reduction of contamination between runs in multi-product use facility).

Can make manufacturing scale decisions much closer to time when material is actually needed and more reflective of actual clinical and market demand.

Lower upfront costs (capital investment) to establish facility and facility can be operational and validated faster than traditional large scale bioreactor sites.

Using disposables for production means faster changeover between manufacturing runs and lowers risks of contamination events.

Can use single vendor or source for clinical and commercial production. Thus, less tech transfer costs, less time and money spent on vendor selection.